Strongbridge Biopharma (SBBP) 25 Feb 202019 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to Strongbridge Biopharma Plc Corporate Update and Fourth Quarter 2019 Earnings Conference Call. At this time all participants are in a listen only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]

It is now my pleasure to introduce Lindsay Rocco of Elixir Health Public Relations.

good and Andrew, you, morning everyone. Thank

pleased Strongbridge Biopharma's are conference that year you for today call. us join fourth earnings could XXXX We quarter full and

Dr. are from Chief Wilhoit, and Financial Johnson, this me Chief Officer; Chief morning Lutz, Joining Executive Officer; Strongbridge Commercial Chairman; Officer. Fred Rob Scott Cohen, Medical John

results the subject begin, making actual forward-looking be I remind differ to Before may will and to like we that you that results the that are the company to would during risks uncertainties this discussed call, statements. forward-looking from statements cause in

Reference in Securities detail U.S. to and event these in risks press in the and with and uncertainties Exchange current are disclosed and filings today's made Commission. the periodic company's release

will view accompanying an download go upon access Please Investor/Events/Presentations slides highlighting these the of of company be To please an the Strongbridge Cushing note Scott's sponsored call, that during syndrome initial set and website. slides, opportunity portion and of market in of research. based Publications section the market there to the

be will this following of part company's the same slides online as made presentation, These within of the corporate the section website. call available also

turn now over to the John Johnson. call will I

And for thank morning, us today. joining Thanks, Good Lindsay. everyone. you

community. the reviewing serving I many like call, continued this unmet thank would And of For today's would to to XXXX to needs the primary begin first performance by strong like KEVEYIS. their process periodic of team dedication the for

XX% million the for to range year, million million of increase fourth of $X.X full guidance a exceeding in total million revenue $XX.X million, achieved KEVEYIS revenue the representing over $XX XXXX. in and company's revenues the quarter $XX.X the for $XX

that a starts to be can from of growth retention new patient and this that in resulted referrals attributed steady rates. both has flow improve believe We physicians

million growth this this therefore year. confident guidance $XX we of preliminary XXXX continue and are that we $XX today to million confirmed can our in revenue We for

KEVEYIS. from in of financial have cash with is taken LOGICS and at reporting position, which continued timeframe to beyond one These in growing allowed anticipated actions contribution year quarter extend expect quarter top our the overall XXXX to positive to a realize company's also third fourth XXXX, our results, the us We for margin coupled line the least to runway strengthen results.

complete our approximately program in in RECORLEV remaining that January syndrome. Xth. the XX% phase. projects the approximately to development regard currently titration trial for all enrollment to of LOGICS endogenous reported as Today, is XX% to are Cushing compared With Phase company clinical in complete enrollment announced X and the complete maintenance we the require The patients on

With this progress, over weeks, the to report top data. we to have able guidance our line past six been tighten

of anticipating now this are quarter the year. data top second quarter at during the the line We from of LOGICS reporting the third end or

a completing reiterate as new in I for study to to drug this number the year. team would that plan look this I important upon a and top priorities are and application of RECORLEV like quality the XXXX. preparing execute work milestones for LOGICS with continued among we forward our

over call to turn Fred. I that, With the will not

development John. to activities. you, on update like Thank with would KEVEYIS and I quick a begin lifecycle

we drug As orphan in inclusivity through which exclusivity KEVEYIS currently is in of provided August previously the United have States noted, XXXX. expires data

that for we of stated, protection previously have upon property we based intellectual conducted. working KEVEYIS we As have have possibility the research been obtaining towards the

are we some would to report and that making describe towards to goal pleased that progress briefly our are efforts. We of like

USPTO the PCT With with of XXXX. three have applications the quarter United States, first patents. XX fourth patent the two to four applications. but these families patent these We of all belonging in the filed of filed applications and primary applications in of We

outside working We patent these with counsel applications. prosecute closely to are

manner a using of methods KEVEYIS the in recently revised with product. consistent The proposed to labeling relate claims active the the for FDA in ingredient

we As to business. lifecycle in our we activities applicable engaging stated, have KEVEYIS been development also have previously

modified release study. these the in Phase developed of in are have X we formulation active prototypes Specifically, prototypes currently proprietary a the testing clinical ingredient KEVEYIS, performance of and

Although formulations at will reasons, them disclosing be or the these this formulations are more of or our regarding we performance developed about time optimistic of competitive thinking one we how the details be for might not further. of

further this of second provide to half expect We information the year. in

Now, the provided the syndrome. X we endogenous an Cushing on LOGICS RECORLEV, update for study of this treatment turning morning, Phase to of RECORLEV

We patients and quarter XXXX. the as third of they're second through at top or of on results to the during trial the advance continued expected the end quarter line to track LOGICS deliver

is Please controlled, screening recall placebo phase. a targeting XX withdrawal for study XX that LOGICS comprised blind, phase, which subjects of enrollment therapeutic phases, three is randomized plus a four approximately to double

The at phase, the phase. primary third the of randomized endpoint is the comes end which withdrawal

consist through end Our data space. top line the of will results of this

complete the study. As now patience the John we of mentioned earlier, to enrolled have required XX%

to that results. expected remaining enrollment are the maintenance. announcement needed we When been And of patient precise more timing top the titrating for complete of guidance in we of the all patients provide all enrolled, believe has currently will line

an relates continue can that to submit to submission, believe we after six line results approximately an we logics As are top months NDA NDA reported.

review, XXX which a our of time a for the cycle the is from months NDA submission, if that via expect review cycle active believe is we (b) previously, new XX can (X) PDUFA standard accepted review a pathway. substance NDA we stated a a date the As for of

to I with commercial the over will Scott? who update. will turn that, And a call provide now Scott,

Thank you, and thanks morning, Fred. everyone, us. Good joining for

research. Cushing an slides upon the of portion sponsored company As initial market illustrate in of view of syndrome mentioned set opportunity accompanying earlier, based contains help to our this call the

Presentation Publications and To go the of Strongbridge and please slides, download these to Investor/Events, access website. section the

potential as is being Cushing treatment and begin, we the Before for a RECORLEV endogenous currently syndrome. investigated for reminder,

approved been as the not and safe has FDA, effective. RECORLEV by

research qualitative more XXX slide recently market assessment, an with quantitative endocrinologists. Turning on than landscape which and We three. assessment to conducted depth in included both

of plans. national and both payers conducted qualitative In addition, XX we research regional with major comprised

see to patients syndrome phase can qualitative provider research in treated six range and the leading the last community Cushing you who healthcare endocrinologist XX included XX months. of an average As XX

In XX patients XXX, causes products this The phase malignant syndrome the of was treating without XX evaluate respondents six perceptions for average treated primary the in purpose quantitative to of to current Cushing future assessment months. an research last endogenous patients. phase syndrome and of Cushing

payer slides, needs, we the unmet our to following opportunity related access. the landscape, On will potential key findings discuss the and RECORLEV market

that on in syndrome research slide here patients. four is of XX,XXX the Our approximately US diagnosed Cushing the range in in the prevalence shows

treatment. typically the is first Surgery line

that are treated. research However, our indicated patients approximately of XXXX these pharmacologically

that uncontrolled on about XXXX or endocrinologists remain treatments. patients, patients XXXX those approximately of reported XX% current Importantly,

shown treated illustrated illustrate more shares treatment As approved prescription that current in our market. of have of the Cushing XX% as are the dominant research none unapproved current slide five, And than on the both using unapproved a share the that product products products for patients and options market of syndrome. are here reported for

market leader of the market remains treated. XX% share patients with Ketoconazole

a Cushing has XXXX million for of revenue guided a branded to of million is therapies. only [indiscernible] reminder range approved quarter, the one syndrome As $XXX which to $XXX

their interested also endocrinologists in options. treatment We to new ask indicate

Cushing to see in slide XX% high can syndrome. for six, here new moderate therapies you interest reported than level in As more

highly products. treatment metyrapone are need without experienced are and also levels Only treaters cabergoline new of treaters are XX% of underscore only with highly experienced ketoconazole satisfied; highly options, options Endocrinologist current XX% potential XX% the experienced for satisfaction satisfied. of approved treaters satisfied; treatment particularly

further a may patients indicate Furthermore, the illustrate endocrinologists who which new options. approved endocrinologists general for with considerable number In level were higher treatment uncontrolled, of satisfaction products. reported a need

Phase endocrinologist patients for for results Here on the were of last likely and six slide III published the than was more RECORLEV, perceptions fulfills results clinical prescribe seven, an our to XX% XX unmet SONICS believer reviewing from show clinical we to months, they the in based treating trial recently need. After quarter. RECORLEV pertaining the upon RECORLEV XX% which endocrinologists indicated profile

to Turning data, RECORLEV provider the with and clinical advantages RECORLEV eight. on believe of endocrinologist using gets Cushing slide patient label recognize supporting for comprehensive prescribing directions approved, support. potential may that we If syndrome,

only weekly as and Further, monitoring warns approved. been was the not that ketoconazole it's a syndrome in Cushing ketoconazole Cushing line of indicates use U.S. in FDA prospectively studied liver last As syndrome. a has and well and antifungal, an reminder the label not indicated

pricing to and reimbursement. Turning

As slide you current XXX,XXX annual therapeutics from ranges XXX,XXX see acquisition syndrome Cushing nine, approved on the upon here approximately FDA can the wholesale depending corresponding cost to dose. for and product

wholesale believe that LARs SIGNIFOR cost and provide annual approximately relevant products to if for KORLYMs potential those SIGNIFOR RECORLEV acquisition We wholesale analogs ranges $XXX,XXX. is approximately $XXX,XXX. approved. $XXX,XXX cost annual acquisition

here rare for can payers see slide syndrome formulary treating tier, on Cushing on non-preferred treating As branded products cover current disease. XX, as is typical a products you

use. appropriate payers medical Additionally, prior have ensure all and authorizations necessity to as expected,

payers other products, majority. Some require to not step-edits but non-approved the

and interviews tested RECORLEV regional with I where payers we earlier, range. mentioned national As and conducted we both price XX profile

XX, on ensure to express slide six to management appropriate access RECORLEV. only to illustrated utilization use As of payer for and expect existing willingness nine patients, RECORLEV. patients coverage to out criteria rating, here They provide appropriate of average have an responded to initial

As restricted more cases may expected highly in some payers step-edit. require

XX. slide to Turning

majority to the a dose market for Cushing generation showed all syndrome state in a to the potential than when XXX endocrinologists As profiles market, capture including next products generation clinical future of they RECORLEV more reminder, the share. expect next we of products, to of

new of treatment that may generation part as RECORLEV, useful option. approved next a offer endocrinologists If

can you experience. see to here fully infrastructure our leverage on in As plan we rare XX, slide disease existing

near built advocacy medical key affairs and track patient record with opinion the In has years, to relationships a foster leading last term, continue of our to commercial with a have we maximize success. we aim Over relationships proven and that several groups. team leaders

facing intend sales, well we go and functions strategy. market medical as as to support our core utilize addition, as customer such marketing liaisons analytics to In capabilities as to services such our patient fully

for the slide of which slide this the final Turning portion to XX, is call.

of approach, we're XXXX approximately the XX XXXX to KOLs believe U.S. We across to XX to community field planning currently In reach required will and with the initial the centers launch. approximately pituitary us and facing customer at this resources provide and XXX terms utilize approximately to neuroendocrine to XXX positions our targeting specialists

believe market meaningful can In we syndrome. advance syndrome. summary, are opportunity of are unmet energized eager Cushing And to improvement This we address. to we make significant the lives RECORLEV the truly as hopefully the Cushing may patients product with RECORLEV in for we needs so in this underscores potential research about

who turn financial highlights I'll and up quarter the Rob Lutz our call that, before open we the year review fourth full questions. the to our over With CFO, to for will call

you, Scott. Thank

results Our some on context details the our details, press quarter Rather of full year my runway. of our than will spend all of cash read fourth release provide XXXX. those for through financial today contains and comments and

securities. announcement marketable projections and at previously, XXXX cash, ended through to one $XX for we and our expenditures, QX we As XXXX, KEVEYIS we equivalents based operating past disclosed of which on expect our for least million expected And LOGICS. data our with year line is at top in cash cash least last for

QX from the Our a in in cash part because payment of through was $X benefit burn $X of onetime Nordisk. XXXX million million Novo

fluctuate expect in expenses working We to and operating variability to cash burn due capital.

Additionally, in an we starting comes down average end. because will in expect of KEVEYIS to to trend expect the higher be LOGICS early expenses burn continue as And because we cash later to quarters R&D grow. XXXX will XXXX diminish and

stage when Until late With shareholder asset, goal we fuel for capital ways a raise additional to are regularly evaluate can with will growth we milestones to our revenue upcoming flow, with increasing value. raise cash capital business. of to we how our business the both we producing achieve the and asset fund multiple believe positive there a and

operator, questions. that, And with ready we're for

first our comes Chris of line the question And Instructions] [Operator you. Jefferies. Howerton from with Thank

for that maybe families morning. four for Thanks missed the taking you're or for the I -- real so for good just questions. you Fred. guess, considering using Hi, this one lifecycle much management described the I quick, KEVEYIS. patent

the I there think I just missed before? concepts

KEVEYIS not labeling the and We is are I said product active patent that for around consistent to the call always Chris. applications drug. going families Thanks, that are the the current ingredient they go actually with today's are the on themselves. it, into in details any

to So, details further later. come

Okay.

moving Okay. Well, over. that. went market thanks the kind forward for I research to that guess, Scott of

be not whether dissatisfied I'd current satisfied, that What that treatments. things Slide drivers on of primarily? or of were with they're when couple a the with you current asked why dissatisfaction is -- X, in they're I or endocrinologists interested guess Just treatments

question. Good Scott. is this Chris, Yes,

think risk rose safety had consistent we I think but think, I the that I a them several, one. Improve need tolerability, the to list top benefit of and balance ones cortisol long control were it's the just of and predictable was for the that.

a what related And were think and to points them. while improvements start, top meaningful think the I good to it were end CV then was I rose

they I things among that products were think the X market. those if others So we for looking bring to

it. Got

And to happen of Okay. And RECORLEV is of a guess the this switching a to off terms in I question investors been what's frankly going of I ketoconazole. lot then in payer with label perspective. approval the face of think

conservative certain that will So it off when you is think step-edit step-edit a syndrome? payers. for for talk more you do be? approved therapies other Cushing possibility or about be ketoconazole label for What Will

Another good question Chris.

in secondary RECORLEV. I saw point a research well as we the first think that sense, the work did, that the make clearly primary that as we with research got you I'd is both the

to RECORLEV, inclination they the sense the shown when positive got profile We they a one. number that were cover had

more of there's you plans. and restrictive think plans, restrictive terms I mentioned, sets of always in

for criteria the on that lower think that could ketoconazole. through see some I those you're of as And could think it players, as the be PA what slide referencing, you of I step you bottom one cost that well is those options. see,

I on an ketoconazole. percentage work to regard there presented, we The a set more patients we mentioned We'll there's good earlier are of slides is guess, that have uncontrolled large And in is of also keto. who do within the news, around in fairly that uncontrolled population. that

there's from perspective. believe opportunity we But there that

Cushing's a are particular the do keto and the the Chris, in for difficult in and think Cushing's it's once you when position, in to John. find calls in against pretty themselves a I use that out payers going label. have label

the it, physicians the expect of work is not not we to understand we'll there's as working risks that's the at huge look help a that, developed. potential evidence scientific of with lot be and payers, of So, here. we with this them category payers keto a And as been body patients

a we're them to in work. patients the our physicians as we more require think not payers get to But access. be certainly of to work of to have little going RECORLEV for For patients with plenty getting issues do that may it data terms access, there’ll that reference the bit they

Sure.

readout important Okay. LOGICS pass one all your waiting for And just the maybe and we're operationally, very expected be move for to or quick obviously, then company event that'll approval. to one and a RECORLEV

be in get submitted, kind order what results, a the has that to anticipation should CMC in from perspective aware But, else be positive of other done of of? NDA to anything or we

So, We've that, to NDA what that the we else package. to we future, we now of right of track know. limiter said a And submission on terms that's the let assembly you are rate data we're be LOGICS is where we'll contrary for now. our with But preparation. learn been preparing if the anything expected the The in for in while stand.

Excellent.

so thanks I'll in Well, the taking and Okay. much queue. the questions for hop back

question next And comes with from our you. of line Thank Stifel. Annabel Samimy the

for is Avatar [ph] this Annabel. on that Hi, Jones

pretty highly some you with research. XX% only satisfied six of were that mentioned your compelling presented specifically, market slide prescribers You guys ketoconazole. And on

engaging give physician? logistics of second potential a little as satisfied, the volume and how those launch more you were Can actually And moderately and to too on Thanks. high highly RECORLEV, approach prescribers just any prepare what launch many of you you around anticipate is targeting do prescribers your a question the for satisfied? of just granularity

Yeah, good question.

last start Let first. with me the one

against slide is deploying If preliminary of on XX we potentially about the initial view that and of This then you our kind go targeting slide, would see the last we targets. how resources cover.

prescriptions XXXX a in well endocrinologist see, we'll are neuroendocrine data centers. at around approach the specialist likely XXX as and that XXXX claims XXX diagnostic We to XXXX a there of data. to claim an about U.S. know as use But you looking pituitary

down in So, we territory to really We that the range XXX to in range. against per comes physicians that cover XX the have that think to those. range customer that And that our about of about think range deploying facing targets. XX XXX that we targets should those

tune Now that's kind audiences, and But additional of team working approach it, of do and the to would work facing. of view of that. size our the fine how closer kind we get the we'll refine we launch are to target as have that customer potential to initial

would I the done just and Scott attitudinal have add and some that, segmentation. and also Yeah, team behavioral

reasons, going we're For will we that. to not competitive be But sharing that see from evolve as the continue data to LOGICS.

but to that, some work. And to of these those our reach, going factors. how we've that promotion determine, sure will hit share described Scott's approaches make and be we of not want that I work, but frequency how some everyone's upon we're undertaken that our their calls, with will put just actual But frequently based folks. aware we that

physicians moderate satisfaction? regarding satisfaction And first levels ketoconazole be should the levels question the of of to

Yes.

at I'm we have call. that my don't going deck. follow share what but that broader up. We know And to You I at slide the to look have have, can didn't fingertips, data in I this

have ask Do authorizations in willing are physicians any edit with concerns If one I back the you on physicians how insight the space just the around this more. complete in step fair prior [ph]? push to --

Yeah.

two think in physicians think terms, it, that like mean disease I category general take products It analog think has with to common thing in authorizations it's fairly in I are it's and just, that I prior place. common. doesn't rare this a

to offices And volume think probably prior doing very types I these higher authorizations. used of are that, especially

connection to provide support we'll education the as on physicians, learn and requirements may more. physicians So, our appropriate we we under And payers for as have. care them will program to educate the get closer launch launch, we

Thank you.

Singh Hartaj with from Thank question you. the And Oppenheimer. of next line our comes

just follow-up from thank have questions couple ones. earlier questions. of Great, I you a my for

likely positive assuming be RECORLEV of be uncontrolled you the if you for to launch? do that Just LOGICS think sort patients candidates think and more a specifically will

what be satisfaction mix you that saw then there's think where you you in And a the both. and ketoconazole other the do with patients, existing or of it'd one low or at drugs slides know, your

Just I a points. any color follow-up And help? couple there just got of would really

question. Good Yes.

We've of frankly, think I we've bit -- probably work. both. got more John it's little a as some mentioned, got

some on not to in have initial kind of now. particular ketoconazole behavioral We share which the done we're with work segments, going

that I uncontrolled. goes number research But I through are think a those it's switching of category the that heard the think may on We anyway. and in potential believe that that both, indicate

So irrespective uncontrolled. reason the be of opportunity, that that they're could an

there be that to don't physicians opportunities behavioral or certain from And I products. think certain may a target utilize perspective, that utilize

Great. Thank then fairly to you. area will post lot ICER, database, would with robust logics? where that consider there's also of pharmaco-economic in prior modeling. And lot have and you probably And then do a you the generics, there appears think a of this consulting require launching you I pharmaco-economic assume drug?

very good a It's question.

to potential I a Clearly how data pharmaco-economic too on on probably with a or engage, ICER this not, make how be we is the and option. TBD think, illness would with any we But in due a payers us early engage call at if discussing point associated the and view of course, for particular. we that. RECORLEV treatment little with product as would we'll burden in the

to Are on talking I'm the KEVEYIS. And long you. second -- half I fascinating. think thoughts question acting about Thank you're version? really seeing was you just last Great. looking it forward your year. Do on you afraid thought that

disease, with again, periodic all periodic the like disease that of any questions. you a And think because are acting there? potentially in like for increase an paralysis, you I harder acting thoughts paralysis, you could short drugs data the KEVEYIS just long number thank actually episodic episodic patients, to Do imagine of

say point we formulation, release hours I way anything current it Hartaj, modified long so. a although long And an XX of by that about release. clarification, formulation of formulation, said also out KEVEYIS, acting our would didn't in very is So we has half-life, approximately or immediate

expect trough the cycling steady, a any go state it's as don't very you So with might basically through short drug. substantial acting patients

drug of board, fair doses. they lower So on keep at amount even a the

the terms is are we're And the just thinking your all promise forthcoming. much to the optimistic, can we modified at say release of point, more that is that is we’ll in addresses although But this not so right details when disclose we hopefully our But time I of question. around ready that. be

Great. Thank for all you questions. the

our And next with question from Thank Esther Montgomery Hong you. line of comes the Janney Scott. [ph]

morning. good Hi,

year, about that how and osilodrostat X this SONICS soon Phase expected later competitive think both the speak landscape early Cushing and you data in of year. next Cushing? Thanks. fit RECORLEV NDA Can treatment with for the approaching, So and submission maybe would potential you nextgen osilodrostat specifically

thanks. Yeah. So

study data. X is to we're that for just this LOGICS the waiting So clarify Phase

I am My sorry. bad.

Yeah, the of no worries. quarter. At third or the quarter end second

slide, a what are was the that including the FDA. to part Medicines In which by landscape in approved out some European of approval his Scott the terms think drugs generation recently Agency, pointed osilodrostat, of next of by the is next be generation, we awaiting likely

And then misoprostol. from generation which [indiscernible], called another next of drug in so Phase the version X RECORLEV is is the drug

that So current are of drugs. we on of think two what profiles a handle we those have good pretty the

as waiting enzyme we're on It cortisol emerge. the the more as them is acts aldosterone. responsible both of high for is of Osilodrostat potency an of the one. synthesis well synthesis with hydroxylase. It that enzymes against And to specifically is cortisol, very XX details one inhibitor. for narrow adrenal Obviously, beta

main that mechanism along The terms different RECORLEV cortisol drugs the is synthesis. now blocks enzyme. to between enzymes pathway in two difference also of that RECORLEV several blocks the lead that

a with the that activity of basically you androgen So osilodrostat. with a way, RECORLEV in blockage you and synthesis that get get cortisol pathways along don't

one only when the under ACTH be not are occurs, that feedback ACTH other increasing up, control the too feedback, steroids When all from when of steroid technical, go production. of adrenal disinhibition the get you you that synthesis. and to driving So the pituitary enzymes, but get can block

go as that's androgens. up, is metyrapone precursors things do the or see or specific aldosterone, tend mineralocorticoid production like dug with to to block osilodrostat well a that So very like the a as you weak mineralocorticoid,

blocker. types in unfavorable considered of are cortisol effects a Those

not perhaps anything for X You cortisol, in gland, production would do or precursors a do block androgen but adrenal increase blocker little. the very block to cortisol prefer

point so Osilodrostat a of there. it And acting in metyrapone the is longer as can differentiation that's potent think that very form and of main regard. that you

Thank you.

I'm you. turn Johnson for back I further time. over Executive showing the the closing will any at this Thank call remarks. John no now to questions Chairman,

XXXX Thank The body to year important solid summary, contribution the KEVEYIS contribution XXXX to be would approaching patients an conclusion. heads with of all part the moment Cushing's I is you. positive for Strongbridge. was scientific In to and their became take LOGICS trial momentum. of for a thank margin its the into like evidence. trial who agreed to

with market combined the expressed initial The interest area RECORLEV, confidence in launch. impressive. approved, prescribing if provides by findings research successful in potential physicians a disease endocrinologists this were increased in These with

all our for of their for we support. call on behalf serve. dedication the Finally, Thank employees thank like and and and I physicians continued to for of would patients your joining continued support you today's

call. conference Thank for participating. this today's Ladies concludes you gentlemen, and

now You disconnect. may